BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELLSEARCH CIRCULATING TUMOR CELL KIT

    MDR report key: 1099508 · Received August 4, 2008

    Report

    Report Number
    3004582358-2008-00004
    Event Type
    Other
    Date Received
    August 4, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 5, 2008
    Manufacturer
    VERIDEX LLC
    Product Code
    NQI
    PMA / PMN Number
    K073338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CTS FOLLOWED UP WITH THE CUSTOMER AND PROVIDED THEM WITH PRODUCT DETAILS. CUSTOMER SATISFIED AND HAS AGREED TO CONTACT CTS IN THE EVENT OF ANY ADDITIONAL INFORMATION IS REQUIRED. THE INFO PROVIDED TO THE CUSTOMER WAS THE FOLLOWING: THE DONORS ARE TESTED FOR VIRAL PARTICULATE CONTAMINANTS AND WERE ALL CONFIRMED TO BE NEGATIVE. THERE IS LITERATURE THAT SUPPORTS THE FIXATION PROCESS THESE CELLS GO THROUGH SHOULD POTENTIALLY REMOVE ANY POSSIBLE VIRAL TRANSMISSION AGENTS. WHILE THE RISK IS VERY LOW, THERE IS NO DATA ON SPECIFIC VIRUSES OR PRIONS, SO TOTAL SAFETY CANNOT BE ASSURED. THEREFORE IT IS STILL RECOMMEND UNIVERSAL PRECAUTIONS WITH THIS PRODUCT. CTS AGAIN REFERRED THE CUSTOMER TO THE MSDS SHEET TO THE CONTROL KIT WHICH INDICATES, "NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTION AGENTS." THE RISK FOR BLOOD BORNE DISEASE IS EXTREMELY LOW. THE CONTROL CELLS CONTAINS 0.1% SODIUM AZIDE. THE HEALTH HAZARD INFO POSTED IN THE MSDS SHEET FOR THE PRODUCT HAS BEEN LABELED AS A SEVERITY OF 1 WHICH IS CONSIDERED A SLIGHT HAZARD. CUSTOMER RECEIVED MEDICAL ATTENTION, WHICH INCLUDED A HEPATITIS B VACCINE INJECTION. THE INCIDENT WAS REPORTED TO THEIR FACILITIES' EXPOSURE CONTROL DEPARTMENT.

    Description of Event or Problem · 1

    CUSTOMER, LEAD RESEARCH TECHNICIAN, REPORTED ON BEHALF OF A COLLEAGUE THAT HAS BEEN EXPOSED VIA SPLASH TO THE EYE WITH THE CTC (CIRCULATING TUMOR CELL) CONTROL CELL IN THE 3ML VIALS. CUSTOMER REPORTS THAT THE USER WAS IN THE PROCESS OF TRANSFERRING THE CONTROL CELLS (B) (4) FROM THE 3ML VIAL TO A CONICAL TUBE. A DROPLET OF THE CONTROL CELL HAD SPLASHED IN THE USER'S EYE. CUSTOMER REPORTS THAT THE USER DID HAVE PROTECTIVE PERSONAL PROTECTION, LAB GOWN, GLOVES AND SAFETY GOGGLES. CUSTOMER REPORTED THAT THE DROPLET MAY HAVE TRAVELED AROUND THE SAFETY GOGGLES. THE CUSTOMER REPORTS THAT THE MSDS (MATERIAL SAFETY DATA SHEET) OF THE CONTROL KIT WAS RETRIEVED OFF OF THE VERIDEX WEBSITE AND THE USER IMMEDIATELY RINSED THEIR EYES WITH PLENTY OF WATER FOR 15 MIN. AT THE TIME OF THE INITIAL COMPLAINT, THE CUSTOMER DID NOT SEEK ANY MEDICAL ATTENTION. CUSTOMER HAS CONTACTED CTS TO OBTAIN ANY ADDITIONAL INFO REGARDING THE RISK ASSESSMENT TO THE EXPOSURE OF THE CELLS THEMSELVES IN THE KIT, SUCH AS VIAL EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLSEARCH CIRCULATING TUMOR CELL KIT CELLSEARCH CTC KIT NQI VERIDEX LLC NA B086

    Patients

    Seq Age Sex Outcome Treatment
    1